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Shezad Malik MD JD
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Trial: Takeda Put Profits Before People with Actos

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According to a key witness who testified in the first trial over allegations that Actos caused bladder cancer, Takeda Pharmaceutical Co., ramped up its Actos diabetes drug sales, while ignoring concerns about patient safety. Takeda Pharmaceutical Co., is Asia’s biggest pharmaceutical manufacturer.

Howard Greenberg, a clinical pharmacologist, testified in state court in Los Angeles today that in 2005, e-mails indicated that there was a discussion whether regulators in the U.S. and Europe might seek warning labels about Actos’s potential links to bladder cancer. According to Greenberg, Takeda officials emphasized protecting the product rather than its users.

Actos History

The U.S. Food and Drug Administration approved Actos for the U.S. market in 1999 and the drug later became the world’s best-selling diabetes treatment.

European Regulators Recalled Actos

Health regulators in Germany and France banned Actos in 2011 after a medical study revealed that some Actos users had an increased risk of developing bladder cancer or heart problems.

Los Angeles California Actos Trial

According to the lawsuit, the plaintiff is Jack Cooper, a retired cable splicer, who was diagnosed with bladder cancer in 2011, according to court filings. He took Actos for more than four years. His lawyer told jurors in opening statements that Cooper had been in “good shape” before he started on the medication. Takeda’s lawyer argued that Cooper’s history as a smoker and his gender put him at higher risk for developing bladder cancer.

"Smoking Gun" Internal Documents

Among the files Greenberg reviewed was an August 2005 e- mail from Takeda executive Kiyoshi Kitazawa on regulators’ concerns about Actos’ cancer links.

“Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Kitazawa said.

Worst-Case Scenario

Takeda officials said that the “worst-case scenario” would be for regulators to mandate the inclusion of a bladder cancer warning on Actos’s label, according to the e-mail.

The case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles).